Divalproex Sodium

Treats manic or mixed episodes associated with bipolar disorder, with or without…. ANDA 202419, held by Aurobindo Pharma Ltd. Divalproex Sodium.

As of Nov 14, 2026, ANDA 202419 (Divalproex Sodium), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 2, 2014, with 21 approved supplements and 0 published complete response letters.

First approved: Jun 2, 2014
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Divalproex sodium extended-release tablets are indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Prophylaxis of migraine headaches 1.1 Mania Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Jun 2, 2014	Original application	Approved	None posted

Products

2 strengths and forms


Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, extended release;oral	Divalproex Sodium	Rx
Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, extended release;oral	Divalproex Sodium	Rx

All 22 submissions, including labeling and manufacturing supplements


Jun 15, 2026	Supplement 33Labeling · Standard review	Approved	None posted
Jun 15, 2026	Supplement 32Labeling · Standard review	Approved	None posted
Mar 27, 2025	Supplement 31Labeling · Standard review	Approved	None posted
Jun 3, 2024	Supplement 29Labeling · Standard review	Approved	None posted
Jul 11, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Dec 27, 2022	Supplement 25Labeling · Standard review	Approved	None posted
Dec 27, 2022	Supplement 22Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Sep 23, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Sep 23, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Sep 23, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Jun 2, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202419
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters